Hand-held Fundus Camera

（Model ：HFC）

Operating Manual

V1.0 July. 2015

2

Preface

Thank you for purchasing our HFC (Handheld Fundus Camera). Please read this manual carefully

before using this instrument in order to operate it properly and safely.

Scope of Application

Hand-held Fundus Camera is used to record magnified images of the ocular fundus through the

pupil.

Product contraindications:N/A

Symbols

Notice: please read precautions and operating instructions in operation

manual

Type B applied part

Date of manufacture.

Manufacture

Please refer to the instructions for use.

Don’t throw away.

Keep dry

Fragile

Upward

Handle with care

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Cautions

Please read carefully about following cautions to avoid unexpected personal injury as well as the

product being damaged and other possible dangers.

Do not use this instrument in the environment prone to fire and blast or where there is much

dust and with high temperature. Use it in the room and simultaneously be careful to keep it

clean and dry.

Always use the HFC in accordance with the directions and recommendations contained in

this User Manual.

When operating this product, please do not use optical lens to touch the eyes or nose of

patient, avoiding harm to the patient.

Avoid subjecting the HFC to vibration or shock. When the product is not in use, please

disconnect the power plug and keep it in a safe place.

Before operation, please make sure the unit appears no damage or break. If there are breaks

in the device cover or other visual defects, please contact Microclear.

Only use Li-ion Battery 3.6V2200mAh which shall be provided by Microclear.

If you purchase different memory capacity of SD Card it must be formatted to FAT32.

Do not increase the illumination light more than required, otherwise harmful to the eye.

For illumination and photography, do not select much higher exposure than required. Do not

illuminate the eye over the normal exam time, otherwise, harm may be caused to the eyes.

WARNING: Do not modify this equipment without authorization of the manufacturer.

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Contents Preface ................................................................................................................................................................. 2

Scope of Application ........................................................................................................................................... 2

Cautions ............................................................................................................................................................... 3

Structure instruction ........................................................................................................................................... 5

1. Intended Use ........................................................................................................................................... 5

2. User Interface .......................................................................................................................................... 5

Operation ............................................................................................................................................................. 8

1. Battery Installation .................................................................................................................................. 8

2. Lens Installation ....................................................................................................................................... 8

3. How to Take a Picture .............................................................................................................................. 9

4. Image display .........................................................................................................................................10

5. Data Transferring ...................................................................................................................................11

6. Battery charging ....................................................................................................................................11

7. Power Indicator .....................................................................................................................................12

8. Battery Replacement .............................................................................................................................12

9. Maintenance ..........................................................................................................................................13

Technical Specifications ....................................................................................................................................14

1. Operation Environment .........................................................................................................................14

2. Storage Environment .............................................................................................................................14

3. Technical Description.............................................................................................................................14

4. Classifcation ...........................................................................................................................................15

5. Liability ...................................................................................................................................................15

6. Warranty ................................................................................................................................................16

7. Standards ...............................................................................................................................................16

8. Attention ................................................................................................................................................16

9. Packing list .............................................................................................................................................17

10.EMC Information ..................................................................................................................................17

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Structure instruction

1. Intended Use

Hand-held Fundus Camera is used to record magnified images of the ocular fundus through the

pupil.

2. User Interface

Front View

LCD Monitor

Picture Mode

Reduce Light Level

Menu

Increase Light Level

Home: Capture/Enter

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Top View

Rear View

Power Button

Lens Connect Ring

Lens Assembling Mark

Lens Connecting Pins

Focus Wheel

Battery Cover

7

Note：AV port is reserved for later use.

Bottom View and Memory Slot

Optical Lens of Digital Fundus Scope

AV out

Mini USB Micro SD Slot

8

Operation

1. Battery Installation

Pry Open the battery cover and remove the cover by lifting it up.

2. Lens Installation

Step 1: Align the mark of the Optical Lens and Control Unit.

Step 2: Hold Optical Lens and attach it on Control Unit.

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Step 3: Rotate and fasten Optical Lens as shown until the lens stops.

3. How to Take a Picture

Step 1: Please press the switch on the top of the device for

about 5 seconds, and it will take 5-8 seconds to start up.

Step 2: Please turn the focus wheel to get clear view of the anterior

segment, then get closer to the eye and slightly turn focus wheel

till clear image on screen.

Step 3: Please hold the handle with your right hand, and use your left hand to prop the lens up

between your thumb and index finger as well as put your left hand palm on the forehead of the

patient, then keep the lens steady with 15°to horizontal.

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Step 4: Please aim at white spot on pupil and push in slightly to fit closely to the orbit with eye

patch.

Step 5: Please make sure fundus image fully fills the field of view as well as slightly adjust the focus

till the vessels shows clear enough, then take a photo

Step 6: Get high definition fundus image.

4. Image display

Press “camera”button to take photo and store automatically .

After getting pictures, press “＋” or “－” button to magnify or diminish the image, checking

more images by pressing ▲/▼

Press “Menu” to display/delete image, checking stored images by pressing ▲/▼

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5. Data Transferring

Place the HFC in the station and connect the mini USB cable to the station.

The computer must meet CE or other related international safety standards.

Connector to computer for data transfer.

6. Battery charging

Place the HFC in the station and connect the mini USB cable to the station.

Connector to computer/transformer for recharging.

Connector

Mini USB slot

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7. Power Indicator

Power Indicator Color Status

Green Light Battery is higher than 25% when the unit is ON

Orange Light Flashing Battery is lower than 25% when the unit is ON

Orange Light Recharging mode

No Light The unit is power OFF.

8. Battery Replacement

Open the battery cover by digging out the gap in the bottom of battery cover with a finger or

something pointed.

Remove the battery cover by lifting up.

Remove the original battery and replace with a new battery, making sure to keep the battery

facing the correction direction.

Re-cover the battery cover.

Warning:Incorrect way of battery replacement will cause HFC not to start up normally.

+

-

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9. Maintenance

9.1Battery and charger safe use and maintenance

1) Please do not recharge and use different model battery to avoid probable explosion or

severe damage.

2) Lithium battery has no memory function, so it can be recharged with left electricity inside,

not reducing its capacity.

3) Lithium battery is not allowed to over time use when the power indicator turns to orange,

please stop use and recharge it.

4) There is over recharging protecting function for the battery, so please do not worry about

over recharging.

5) All rechargeable batteries have maximum recharging and releasing times, please do not

frequently recharge and release electricity.

6) Lithium battery will work in its best condition between 0℃ to 35℃. At too low or too high

temperature, it will not work well, so please do not recharge it at lower than 0℃ or higher

than 40℃.

7) If the device is in stock for long time, please fully recharge the battery and take it out of the

device, then store it separately.

8) If the battery is broken, replace it with batteries supplied by Suzhou Microclear Medical

Instruments Co., Ltd

If wrong type of battery is used, there can be fire hazard.

9) Please do not place the battery together with metal things in a pocket to avoid short circuit

causing fire.

10) Please do not use broken battery or battery without shell.

11) Please make battery short circuit, or take apart it, or throw it in fire.

12) Please use charger supplied by our company to recharge the battery.

13) If the power indicator darkens or light off, please recharge.

14) After fully recharging the battery, please disconnect the device with charger, over

recharging may cause damage to battery.

15) A battery can be recharged more than 300 times. Recharging times depends on left power

in battery during recharging, the less the power is , the longer battery working life will be.

16) After recharging or not using charger, please unplug the charger.

17) During recharging, please do not cover the charger to avoid fire.

9.2 Maintenance

The HFC is a precision photo-electronic instrument that shall be handled with specific care.

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Please note the following cleaning instructions:

Power off the HFC before cleaning it.

It is recommended to clean the optical lens with cleaning cloth or lens cleaning tissue.

Not using HFC for a long time, please take out the battery and place it separately.And

please recharge it once a month.

HFC needs to be cleaned once a week.

Battery maintenance and precaution

Technical Specifications

1. Operation Environment

Ambient temperature 0℃ to +35℃

Relative humidity range 10% to 80%

Atmospheric pressure 760hPa ~ 1060hPa

2. Storage Environment

Ambient temperature -10℃ to 40℃

Relative humidity range ≤80%

Air pressure: 760hPa~1060hPa

Production date: See product label

Note: It is recommended to remove the battery if the HFC is stored more than 2 weeks.

3. Technical Description

Power Source: Rechargeable Lithium battery model：NCM18650-220 3.6V / 2200mAh made in

DLG

Dimension: 16×9×19cm3

Weight: 450Grams(Typical)

View Angle: 40 Degree(Typical)

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Diopter: -20D ~ +20D

Focus: Manual Focus

Camera Resolution: 1920×1080 pixels

Search Fundus Lighting: Two modes, natural white Light Emitting Diode(LED) or infrared LED

Camera / video flash: Natural white LED

LCD Monitor: 3.5〞Full Color TFT-LCD

Image Format: JPEG(Photograph)

Interface: Mini USB

File Transfer: Mini USB Port to PC

File Storage: SD card up to 16G.

Fuse：Fuse model：REOMAX12.000.2 Size: 3.2*1.6*0.65mm Amps：2A Volts:72VDC

4. Classifcation

Electrical protection: internal power equipment

Applied part: Type B

Mode of operation: Continuous operation

Ingress protection: IPX0

Not AP/APG equipment

5. Liability

Microclear considers itself responsible for the effects on safety, reliability and performance of this

product only if:

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

persons authorized.

The electrical installation of the relevant room complies with the requirements.

The equipment is used in accordance with these instructions for use.

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6. Warranty

Microclear provides the HFC one year warranty for the parts. Warranty for battery is six

months.

The warranty starts at delivery date.

Natural disasters, man-made damage, lack of reasonable care, disassembly, upgrade, warranty

sticker torn off, or any phase-out parts are not included in the warranty.

7. Standards

Electrical safety IEC 60601-1 : 2005 + A1: 2012 (EN 60601-1 : 2006 + A1: 2013)

EMC and regulatory compliance IEC 60601-1-2 : 2007(EN 60601-1-2 : 2007)

Wellkang Ltd t/a Wellkang Tech Consulting,

(Suite B,29 Harley Street LONDON W1G 9QR England, United Kingdom)

8. Attention

If the user’s qualified technician repairs the repairable parts designated by producer, please

contact the producer to ask for circuit diagram, component list,figure,detailed correction

rules,etc.

Environment protection: The producer shall collect and dispose the replaced circuit board,

control board and power supply box, in order to reduce environment pollution. At the end of the

device working life, the producer should do product tracking and recycle the waste camera

according to local regulations.

Fundus camera and its function can be affected by electromagnetic interference, so please make

sure be far away from magnetic objects and strong magnetic field(≥1mT).

Fundus camera produces and releases electromagnetic energy,and normal use will not interfere

with other equipment. Incorrect installation or incorrect use may affect other equipment.

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9. Packing list

Hand-held fundus camera control unit 1

Hand-held fundus camera lens tube 1

Power supply adapter 1

USB cable 1

Charger 1

Battery 18650(Model No.) 1

Eye patch 1

User manual 1

Software disk 1

Dust cover 1

10.EMC Information

Guidance and manufacturer’s declaration - electromagnetic emissions - for all ME

EQUIPMENT and ME SYSTEM.

Table 1:Guidance and manufacturer’s declaration – electromagnetic emissions

The HFC is intended for use in the electromagnetic environment specified below. The customer or the

user of the HFC should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1 The HFC uses RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in nearby

electronic equipment

RF emissions

CISPR 11

Class A

The HFC is suitable for use in all establishments

other than domesticand those directly connected to

the public low-voltage power supply network that

supplies buildings used for domestic purposes

Harmonic emissions

IEC 61000-3-2

A

Voltage fluctuations/

Flicker emissions

IEC 61000-3-3

Complies

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Guidance and manufacturer’s declaration - electromagnetic immunity - for all ME

EQUIPMENT and ME SYSTEM.

Table 2:Guidance and manufacturer’s declaration – electromagnetic immunity

The HFC is intended for use in the electromagnetic environment specified below. The customer or the

user of the HFC should assure that it is used in such an environment.

Immunity test IEC 60601

Test level

Compliance

level

Electromagnetic environment -

guidance

Electrostatic

Discharge(ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV

contact

±8 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast

transient/burst

IEC 61000-4-4

±2 kV for power

supply lines

±2 kV for

power

supply lines

Mains power quality should be that of a

typical commercial or hospital

environment

Surge

IEC 61000-4-5

±1 kV lines to lines

±2 kV lines to earth

±1 kV lines

to lines

±2 kV lines

to earth

Mains power quality should be that of a

typical commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

<5% UT

(>95% dip in UT)

For 0,5 cycle

40% UT

(60% dip in UT)

For 5 cycle

70% UT

(30% dip in UT)

For 25 cycle

<5% UT

(>95% dip in UT)

For 5 cycle

<5% UT

(>95% dip in

UT)

For 0,5 cycle

40% UT

(60% dip in

UT)

For 5 cycle

70% UT

(30% dip in

UT)

For 25 cycle

<5% UT

(>95% dip in

UT)

For 5 cycle

Mains power quality should be that of a

typical commercial or hospital

environment. If the user of HFC

requires continued operation during

power mains interruptions, it is

recommended that the HFC be powered

from an uninterruptible power supply or

a battery.

Power frequency 3A/m 3A/m Power frequency magnetic fields should

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(50/60Hz) magnetic

field

IEC 61000-4-8

be at levels characteristic of a typical

location in a typical commercial or

hospital environment

Note: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity for ME EQUIPMENT and

ME SYSTEM that are not LIFE-SUPPORTING.

Table 3: Guidance and manufacturer’s declaration – electromagnetic immunity

The HFC is intended for use in the electromagnetic environment specified below. The customer or the

user of the HFC should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance

level

Electromagnetic environment-guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80MHz

3 Vrms

80MHz to 2.5GHz

3V

3V/m

Portable and mobile RF communications

equipment should be used no closer to any

part of the SYSTEM,including cables, than

the recommended separation distance

calculated from the equation applicable to

the frequency of the transmitter.

Recommended separation distance

PV

d ]5.3

[1

PE

d ]5.3

[1

80MHz to 800MHz

PE

d ]7

[1

800MHz to 2.5GHz

Where P is the maximum output power

rating of the transmitter in watts(W)

according to the transmitter manufacturer

and d is the recommended separation

distance in metres (m).

Field strengths from fixed RF transmitters,

as determined by an electromagnetic site

survey, should be less than the compliance

level in each frequency range.

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Interference may occur in the vicinity of

equipment marked wigh the following

symbol:

Recommended separation distances between portable and mobile RF communications equipment and the ME

EQUIPMENT and ME SYSTEM – for ME EQUIPMENT and ME SYSTEM that are not

LIFE-SUPPORTING.

Recommended separation distances between portable and mobile RF communications equipment and

the HFC

The HFC is intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of the HFC can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the HFC as recommended below, according to the maximum output power of the

communications equipment.

Rated maximum

output power of

transmitter

W

Separation distance according to frequency of transmitter

m

150kHz to 80 MHz

PV

d ]5.3

[1

80MHz to 800MHz

PE

d ]5.3

[1

800MHz to 2.5GHz

PE

d ]7

[1

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

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